Eye DiseasesNCT04334499
Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.
An observational study of Eye Diseases and Ophthalmic Trauma, run by The University of Texas Medical Branch, Galveston.
Trial summary
This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Ophthalmic Trauma, Mitochondrial DNA
- What is being tested?
- Sample collection from tissue discard
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 Feb 2020to 7 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects suffering eye disease or ocular trauma and healthy subjects undergoing ocular surgery which may include the discard of vitreous humor.
Who may be able to join
- a) Target group
- Age ≥ 20 years old
- Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential. Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
- Scheduled ophthalmic surgery with expected vitreal humor discard.
- Subject has provided written informed consent to participate in this protocol. b) Control group
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- Age ≥ 20 years old
- Subjects must not be nursing, pregnant or planning to become pregnant. Subjects of child bearing potential must have a documented negative pregnancy test at the time of preoperative assessment or not be of child bearing potential.
- Lack of identified eye disease.
- Scheduled ophthalmic surgery with expected vitreal humor discard.
- Subject has provided written informed consent to participate in this protocol.
Who cannot join
- a) Target group
- Age < 20 years old
- Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
- Identified eye disease including but not limited to age-related macular degeneration, glaucoma and/or diabetic retinopathy.
- Subject has not completed informed consent to participate in this protocol. b) Scheduled ophthalmic surgery with expected vitreal humor discard Control group
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- Age < 20 years old
- Subject is nursing, pregnant, planning to become pregnant or of child bearing potential and does not agree to the use of reliable method of contraception during their participation in the study. A pregnancy test must be administered to women of childbearing potential at the time of preoperative assessment.
- Lack of identified eye disease.
- Subject has not completed informed consent to participate in this protocol. Scheduled ophthalmic surgery with expected vitreal humor discard.
About this study
Official title: Investigation of the Relationship Between Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.
This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. This protocol examines the use of mtDNA populations as indicators of developing inflammation and resolution of injury. This may be used to provide proactive treatment or define appropriate treatment needs beyond the indications of an ophthalmological exam.
Read the detailed description
The study aim to test correlation between the presence of the mitochondrial DNA in vitreous fluid and blood in patients that are admitted to UTMB's Eye clinic. The goal of the study is to analyze 4 groups of 30 samples of each major ocular disease and injury: age-related macular degeneration, glaucoma and diabetic retinopathy and ocular trauma. Up to 300 subjects may be consented to this study in order to meet recruitment goals. In this study we will use only otherwise discarded eye's vitreous together with a blood sample that is collected during surgery. Patients with ophthalmic surgery scheduled that may result in discarded vitreal fluid will be identified from the clinic schedule or by physician in the emergency room. The possibility of vitreous collection in a surgery may be uncertain. If a subject does not have discarded vitreous from a given surgery they will be screen failed prior to blood draw or data collection from electronic medical record from that moment forward. Subjects will be approached when appropriate for interest in participation in the study by their clinical faculty surgeon. An informed consent briefing will be provided by the clinical research coordinator with an opportunity to ask questions of both the coordinator, the clinical faculty surgeon and the principle investigator. Copies of the consent will be provided for the patient to take home. Additional opportunity for questions the morning of surgery will be provided. Consent signature will be obtained prior to any medication administration the upon admission for surgery. Samples if available will be collected during the eye surgery. Up to 1ml of vitreous fluid and up to 10 ml of blood will be collected from each patient. Samples will be stored at room temperature and transferred directly to Dr. Szczesny's laboratory. Vitreous fluid will be frozen for further analysis and blood plasma will be processed using histopaque and centrifugation prior freezing. Two types of analysis will be conducted with collected biospecimens.1) Total DNA will be isolated, follow by analysis with real-time quantitative polymerase chain reaction (RTq-PCR) using set of primers to identify the presence of the mitochondrial DNA and nuclear DNA as a control. 2) Extracellular vesicles will be isolated using ultracentrifugation or commercially available kit followed by analysis of the mitochondrial and nuclear DNA and/or plasma membrane markers using RTq-PCR and/or Western blot. Electronic medical records will be accessed to collect demographics and ophthalmologic diagnostic information and information on other comorbidity diagnoses.
These data points will include age in years, gender, race, ethnicity, presence of age related macular degeneration(AMD) (y/n), type and stage of AMD, use of AREDs vitamins, treatments of AMD, Glaucoma(y/n), type and stage of glaucoma, diabetes, blood glucose, diabetic retinopathy (y/n), type and stage of diabetic retinopathy, treatments of diabetic retinopathy and amount of time prior to this planned surgery, hypertension type and stage, renal disease type and stage, smoking history, cancer, cancer type, treatment or surgery, viral diagnoses (HIV, CMV, HCV), blunt eye trauma history, cataract history, lens removal surgery, cause of vitrectomy, concomitant medications and procedures, eye exam observations relevant to inflammatory processes, Optical coherence tomography data. IOP, visual field [VF] data, visual acuity, gonioscopic findings,.
- Conditions
- Eye Diseases, Ophthalmic Trauma, Mitochondrial DNA, Age Related Macular Degeneration, Glaucoma, Diabetic Retinopathy
- Being tested
- Sample collection from tissue discard
- Keywords
- mitochondrial DNA, opthalmic trauma, age related macular degeneration, glaucoma, inflammation, inflammatory marker, diabetic retinopathy
- Medical subject headings
- Eye Diseases, Macular Degeneration, Glaucoma, Diabetic Retinopathy, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collection from tissue discardOther
Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
| Study group | Role | What they receive |
|---|---|---|
| Age Related Macular Degeneration | Subjects with Age Related Macular Degeneration upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. Receives: Other: Sample collection from tissue discard | |
| Glaucoma | Subjects with Glaucoma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. Receives: Other: Sample collection from tissue discard | |
| Diabetic Retinopathy | Subjects with Diabetic Retinopathy upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. Receives: Other: Sample collection from tissue discard | |
| Ocular Trauma | Subjects with Ocular Trauma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. Receives: Other: Sample collection from tissue discard | |
| Control | Subjects with no ocular disease or trauma comorbidities upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. Receives: Other: Sample collection from tissue discard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitation of mitochondrial DNA in vitreous humor and serum samples
mtDNA quantitation by RTq-PCR
Measured: 1 day
Secondary outcomes (1)
Evaluation of mtDNA quantitation versus ocular comorbidities as described in electronic medical record.
Collection of comorbidity data from electronic medical record and comparison with quantiative analysis of mtDNA.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start21 Feb 2020
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Why it stopped: The study was never initiated; Principal Investigator determined that it was not feasible to continue with the study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bartosz Szczesny, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334499
- Sponsor's protocol ID
- 19-0291
- Status last verified
- Mar 2023
- First submitted
- 1 Apr 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study records will be kept confidential as required by law. Except when required by law, your identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). For records disclosed outside of UTMB, you will be assigned a unique code number. The key to this code will be kept in a password protected encrypted format on a limited access server behind the UTMB firewall. It will be destroyed at the end of data collection for this study. Study samples will also be kept in a de-identified state with the same 4 digit code as the data collection. These samples will be maintained in secured laboratories of the Department of Ophthalmology. The de-identified samples may be maintained past the end of the study for future research without additional consent. Future researchers will have no information on the identity of the subjects.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Mitochondrial DNA in Vitreous Fluid and Blood in Patients With Eye Disease or Ocular Trauma.
- ClinicalTrials.gov ID
- NCT04334499
- Acronym / sponsor ID
- 19-0291
- Conditions
- Eye Diseases, Ophthalmic Trauma, Mitochondrial DNA, Age Related Macular Degeneration, Glaucoma, Diabetic Retinopathy
- Keywords
- mitochondrial DNA, opthalmic trauma, age related macular degeneration, glaucoma, inflammation, inflammatory marker, diabetic retinopathy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was never initiated; Principal Investigator determined that it was not feasible to continue with the study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 21 Feb 2020 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to characterize mitochondrial DNA (mtDNA) populations in adults with eye injuries and eye diseases. The eye exam is often hindered by the clouding of tissues involved in injury or disease. This protocol examines the use of mtDNA populations as indicators of developing inflammation and resolution of injury. This may be used to provide proactive treatment or define appropriate treatment needs beyond the indications of an ophthalmological exam.
Detailed description
The study aim to test correlation between the presence of the mitochondrial DNA in vitreous fluid and blood in patients that are admitted to UTMB's Eye clinic. The goal of the study is to analyze 4 groups of 30 samples of each major ocular disease and injury: age-related macular degeneration, glaucoma and diabetic retinopathy and ocular trauma. Up to 300 subjects may be consented to this study in order to meet recruitment goals. In this study we will use only otherwise discarded eye's vitreous together with a blood sample that is collected during surgery. Patients with ophthalmic surgery scheduled that may result in discarded vitreal fluid will be identified from the clinic schedule or by physician in the emergency room. The possibility of vitreous collection in a surgery may be uncertain. If a subject does not have discarded vitreous from a given surgery they will be screen failed prior to blood draw or data collection from electronic medical record from that moment forward. Subjects will be approached when appropriate for interest in participation in the study by their clinical faculty surgeon. An informed consent briefing will be provided by the clinical research coordinator with an opportunity to ask questions of both the coordinator, the clinical faculty surgeon and the principle investigator. Copies of the consent will be provided for the patient to take home. Additional opportunity for questions the morning of surgery will be provided. Consent signature will be obtained prior to any medication administration the upon admission for surgery. Samples if available will be collected during the eye surgery. Up to 1ml of vitreous fluid and up to 10 ml of blood will be collected from each patient. Samples will be stored at room temperature and transferred directly to Dr. Szczesny's laboratory. Vitreous fluid will be frozen for further analysis and blood plasma will be processed using histopaque and centrifugation prior freezing. Two types of analysis will be conducted with collected biospecimens.1) Total DNA will be isolated, follow by analysis with real-time quantitative polymerase chain reaction (RTq-PCR) using set of primers to identify the presence of the mitochondrial DNA and nuclear DNA as a control. 2) Extracellular vesicles will be isolated using ultracentrifugation or commercially available kit followed by analysis of the mitochondrial and nuclear DNA and/or plasma membrane markers using RTq-PCR and/or Western blot. Electronic medical records will be accessed to collect demographics and ophthalmologic diagnostic information and information on other comorbidity diagnoses.
These data points will include age in years, gender, race, ethnicity, presence of age related macular degeneration(AMD) (y/n), type and stage of AMD, use of AREDs vitamins, treatments of AMD, Glaucoma(y/n), type and stage of glaucoma, diabetes, blood glucose, diabetic retinopathy (y/n), type and stage of diabetic retinopathy, treatments of diabetic retinopathy and amount of time prior to this planned surgery, hypertension type and stage, renal disease type and stage, smoking history, cancer, cancer type, treatment or surgery, viral diagnoses (HIV, CMV, HCV), blunt eye trauma history, cataract history, lens removal surgery, cause of vitrectomy, concomitant medications and procedures, eye exam observations relevant to inflammatory processes, Optical coherence tomography data. IOP, visual field [VF] data, visual acuity, gonioscopic findings,.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Age Related Macular Degeneration | – | Other: Sample collection from tissue discardSubjects with Age Related Macular Degeneration upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. |
| Glaucoma | – | Other: Sample collection from tissue discardSubjects with Glaucoma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. |
| Diabetic Retinopathy | – | Other: Sample collection from tissue discardSubjects with Diabetic Retinopathy upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. |
| Ocular Trauma | – | Other: Sample collection from tissue discardSubjects with Ocular Trauma upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. |
| Control | – | Other: Sample collection from tissue discardSubjects with no ocular disease or trauma comorbidities upon evaluation for ocular surgery that may involve the discard of vitreous humor tissue. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering eye disease or ocular trauma and healthy subjects undergoing ocular surgery which may include the discard of vitreous humor.
Key inclusion criteria (11 listed)
- a) Target group
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Key exclusion criteria (10 listed)
- a) Target group
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collection from tissue discardCollection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue. | Other | Age Related Macular Degeneration, Control, Diabetic Retinopathy, Glaucoma, Ocular Trauma |
Primary outcome
Quantitation of mitochondrial DNA in vitreous humor and serum samples
Time frame: 1 day
mtDNA quantitation by RTq-PCR
1 secondary outcome
Evaluation of mtDNA quantitation versus ocular comorbidities as described in electronic medical record.
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No. Study records will be kept confidential as required by law. Except when required by law, your identifiers will not be disclosed outside of the University of Texas Medical Branch (UTMB). For records disclosed outside of UTMB, you will be assigned a unique code number. The key to this code will be kept in a password protected encrypted format on a limited access server behind the UTMB firewall. It will be destroyed at the end of data collection for this study. Study samples will also be kept in a de-identified state with the same 4 digit code as the data collection. These samples will be maintained in secured laboratories of the Department of Ophthalmology. The de-identified samples may be maintained past the end of the study for future research without additional consent. Future researchers will have no information on the identity of the subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bartosz Szczesny, Ph.D. principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases and Ophthalmic Trauma, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitation of mitochondrial DNA in vitreous humor and serum samples (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.